On May 09, 2016 Oncothyreon Inc. (NASDAQ:ONTY), a clinical-stage biopharmaceutical company, reported a corporate update and reported financial results for the quarter ended March 31, 2016 (Press release, Oncothyreon, MAY 9, 2016, View Source [SID:1234512124]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the first quarter, the Company continued to advance its portfolio of oncology product candidates and achieved a major milestone with the commencement of the Phase 2 combination trial of ONT-380 with Herceptin and Xeloda in patients with HER2-positive, third-line metastatic breast cancer," said Scott Myers, President and CEO of Oncothyreon.

"In my short tenure so far, it is already clear the Company is committed to making an impact on the lives and outcomes of cancer patients, and I look forward to building upon that foundation," continued Mr. Myers. "In the coming months, the Company plans to review all programs and implement a development strategy for the optimal allocation of resources, with the goal of delivering novel therapies to cancer patients."

First Quarter and Recent Highlights:

Clinical Development:

ONT-380 Phase 2 Combination Trial Underway in Patients with HER2-Positive Breast Cancer. This randomized, double-blind, placebo-controlled trial is evaluating ONT-380 in combination with Herceptin (trastuzumab) and Xeloda (capecitabine). ONT-380 is an oral, HER2-selective, central nervous system (CNS)-active tyrosine kinase inhibitor. The Phase 2 trial is targeted to enroll approximately 180 heavily pretreated patients with advanced HER2-positive breast cancer who present with or without brain metastases. Building on encouraging Phase 1b results, the primary and secondary endpoint objectives are designed to measure ONT-380’s contribution on both systemic and CNS disease, an area of unmet need for patients.

Presentation of data highlighting the preclinical development of orally bioavailable, potent and selective checkpoint kinase 1 (Chk1) inhibitors. Results presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 highlighted preclinical data demonstrating that select Oncothyreon Chk1 inhibitors display cellular potency against Chk1, are active against a diverse range of cancer cell lines and demonstrate synergistic activity in combination with certain chemotherapeutic drugs. The pharmaceutical properties also indicate good metabolic stability and pharmacokinetic properties, with good oral bioavailability in preclinical models. The research was conducted pursuant to a research collaboration agreement with Sentinel Oncology.
Corporate Update:

Appointment of Scott Myers, President and CEO and member of the Board of Directors.
Scott Myers joined Oncothyreon on April 4, 2016. Mr. Myers most recently served as Chief Executive Officer and President for Aerocrine AB, a life sciences company based in Stockholm, Sweden and Morrisville, NC. Aerocrine was acquired by Circassia Pharmaceuticals, a UK-based immunotherapy company, in July of 2015. Mr. Myers also served as an independent Director for Orexo, AB, a pharmaceutical company and is currently an industry advisor to EQT, a large Scandinavian investment fund. Prior to joining Aerocrine in 2011, he served as Vice President, Head of European Mid-Markets for UCB Pharma, SA, a Belgian-based, global biopharmaceutical company. In this role, Mr. Myers oversaw commercial operations and medical affairs for 32 countries in the EU. Prior to UCB, he served in senior roles responsible for business development, strategic marketing and pharmaceutical portfolio management at several leading companies including Johnson & Johnson.

New board members appointed. In January 2016, Oncothyreon appointed new board members Mark Lampert and Gwen Fyfe, M.D. Mr. Lampert brings extensive biotechnology and finance experience to the board. He is the founder of BVF Partners L.P., affiliates of which, including Biotechnology Value Fund, L.P., have been stockholders of Oncothyreon since 2011. Dr. Fyfe previously served as vice president of Genentech’s oncology development group and later as vice president, Avastin Franchise Team at Genentech.
First Quarter 2016 Financial Highlights

Cash, cash equivalents and investments totaled $46.5 million as of March 31, 2016, compared to $56.4 million at December 31, 2015, a decrease of $9.9 million, or 17.6%. The decrease was primarily attributable to cash used to fund operations of $9.8 million.

Net loss for the quarter ended March 31, 2016 was $12.9 million, or $0.14 per basic and diluted share, compared with a net loss of $7.9 million, or $0.08 per basic and diluted share, for the comparable period in 2015. The increase in net loss for the quarter was primarily attributable to increases in general and administrative expenses of $4.3 million primarily related to the retirement and separation agreement that Oncothyreon entered into with its former CEO in January 2016 and increases in research and development expenses of $0.5 million primarily due to greater activity related to the development of the product candidates.
Financial Guidance

Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it.

Oncothyreon currently expects operating expenses in 2016 to be higher than in 2015. This increase will primarily be related to expenditures associated with the Phase 2 trial of ONT-380. Oncothyreon currently expects cash used in operations in 2016 to be approximately $38.0 million to $40.0 million. With cash, cash equivalents and investments of $46.5 million as of March 31, 2016, Oncothyreon estimates that its cash, cash-equivalents and investments will be sufficient to fund operations for at least the next 12 months.

Upcoming Events

ONT-380 Poster Presentation at ASCO (Free ASCO Whitepaper) Annual Meeting:

Abstract 513: "Efficacy results of a phase 1b study of ONT-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases." Virginia F. Borges, MD from the University of Colorado Cancer center will discuss the poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago on Sunday, June 5, 2016, from 11:30 a.m. – 12:45 p.m. CT in Hall D2, with a poster session preceding from 8 a.m. to 11:30 a.m. CT in Hall A.
R & D Day:

Oncothyreon will host an R & D Day in New York City on June 14, 2016. Company management will discuss an overview of the company’s lead product candidate, ONT-380. Several distinguished oncology thought leaders will also participate. This event will be webcast.